RECRUITING

Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

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Conditions

Lower Limb Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.

Official Title

Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods

Quick Facts

Study Start:2025-06-01
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06923293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a lower limb injury greater than a year ago.
  2. * Be 18-80 years old.
  3. * Be able to stand for 30 minutes.
  4. * Have enough range of motion in my ankle to comfortably wear the AFO.
  5. * Be able to follow directions and commands.
  6. * Be willing and able to give informed consent.
  7. * Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.
  1. * Have any joint or muscle tightness that would limit my movement while walking with the AFO.
  2. * Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
  3. * Have any medical issues that affect my unaffected side.
  4. * Have skin issues that would prevent wearing the device.
  5. * Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
  6. * Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
  7. * Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
  8. * Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
  9. * Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.

Contacts and Locations

Study Contact

Kate Goworek
CONTACT
973-324-3560
kgoworek@kesslerfoundation.org

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2027-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Lower Limb Injury